Newsletter summary

Research and Development of Tsuen Xin Bio-B (02509)Lkf777slotQX013N monoclonal antibody was approved in clinical trial.Lkf777slotIt is the first targeted c-kit biological drug in China, which is expected to fill the unmet medical needs of tens of millions of patients with chronic urticaria and enhance the company's market position in the dermatology field.

Text of news flash

[QX013N independently developed by Tsuen Xin Bio-B (02509) has been approved for clinical trials by the State Drug Administration of China]

On May 9, 02509, Tsuen Xin Bio-B (2024) announced that its independently developed humanized IgG1 monoclonal antibody against QX013N had been approved by the Drug Review Center of the State Drug Administration of China for new drug clinical trials. The drug will be used to treat chronic spontaneous urticaria (CSU) and is the first candidate biological drug for c-kit target in China.

CSU is a chronic inflammatory skin disease faced by about 25 million patients in China, and the number of patients is expected to increase to about 29.7 million by 2030. QX013N acts on mast cells, reduces and depletes mast cells by specifically binding to c-kit targets.

The clinical trial approval of QX013N in CSU indications marks a further layout of Tsuen Bio-B in the autoimmune and allergic disease track. The comprehensive layout of the company's four major indications in dermatology has been formed, and the dominant position in the field of dermatology has been further consolidated. In the face of tens of millions of unmet treatment needs of dermatology patients in China, the company will devote itself to more efficient clinical promotion in order to provide patients with more rich treatment options.